Clearance Summary
STRYKER STRI-SHIELD FLYTE TOGAS received FDA 510(k) clearance under submission number K073017, sponsored by Stryker Instruments, Instruments Div.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2007-11-30.
- Submission: K073017
- Applicant / Sponsor: Stryker Instruments, Instruments Div.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2007-11-30
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.